Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-01 @ 5:51 PM
Study NCT ID:
NCT07218250
Status:
RECRUITING
Last Update Posted:
2025-10-17
First Post:
2025-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of a One-Time Counseling Session to Help Reduce Depression, Anxiety, and Distress in People With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2025-10-15', 'studyFirstSubmitQcDate': '2025-10-15', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability (SSC-C participants)', 'timeFrame': 'up to 3 months', 'description': 'Participants will complete a satisfaction survey after completing the SSC-C intervention. A 5-item, investigator- initiated, face-valid satisfaction survey will assess the degree with which participant found SSC-C helpful in developing an action plan to address their concerns, their perceived utility of the action plan, the degree with which they believe they will use the action plan, their motivation to do so, and the extent to which they will recommend SSC-C to other patients.'}, {'measure': 'Acceptability (PPSB participants)', 'timeFrame': 'up to 3 months', 'description': 'Participants will complete a satisfaction survey after receiving PPSB intervention materials. A 6-item, investigator- initiated, face-valid satisfaction survey will assess the degree with which participants found PPSB intervention helpful in developing an action plan to address their concerns, their perceived utility of the booklet, the degree with which they believe they will use the booklet, their motivation to do so, and the extent to which they will recommend the booklet materials to other patients.'}], 'secondaryOutcomes': [{'measure': 'Psychosocial distress', 'timeFrame': 'up to 3 months', 'description': 'The Hospital Anxiety and Depression Scale (HADS) will assess symptoms of anxiety (7 items, range 0-21) and depression (7 items, range 0-21).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Counseling Session', 'Reduce Depression', 'Reduce Anxiety', 'Reduce Distress', '25-281'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if a Single Counseling Session for Cancer can help reduce psychosocial distress and improve quality of life in people with breast cancer who are waiting to receive ongoing counseling services (outpatient psychotherapy services). The Single Counseling Session for Cancer-which I will refer to as the "study counseling" during this call-is a one-session, 60-minute counseling program designed to reduce anxiety and depression symptoms in people with cancer who are waiting to receive outpatient psychotherapy services. The researchers will look at whether the study counseling is effective in participants and practical (feasible) for them to complete.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient must have pathologically confirmed breast cancer (per EMR).\n* Patient with localized or advanced cancer (per EMR).\n* Patient is on a waitlist of at least 2 weeks or more for MSK Counseling Center intake and will not complete a Counseling Center intake prior to intervention (these patients will be replaced) (per EMR, patient's care team, or self-report).\n* Has no current active or passive suicidal ideation (per self-report of PHQ-9, Item 9: Thoughts that you would be better off dead, or of hurting yourself).\n* Female (per EMR)\n* Age ≥ 18 (per EMR)\n* English fluency - Per self-report: How well do you speak English?\n* Agrees to be audio-recorded (per self-report) NOTE: Participants who report Very well are considered fluent.\n* Lives in New York, New Jersey, or Connecticut (per self-report).\n* Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require urgent or extended individual treatment) (per EMR, patient's care team, or study team).\n* Has no presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patient's care team, or per self-report of BOMC cognitive test).\n* Has no current active or passive suicidal ideation (per item 9 of the PHQ-9 and the CSSRS)."}, 'identificationModule': {'nctId': 'NCT07218250', 'briefTitle': 'A Study of a One-Time Counseling Session to Help Reduce Depression, Anxiety, and Distress in People With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Piloting Single Session Consultation for Cancer (SSC-C) to Alleviate Distress Among Breast Cancer Patients', 'orgStudyIdInfo': {'id': '25-281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSC-C - Single Session Consultation for Cancer', 'description': 'will receive the study counseling', 'interventionNames': ['Behavioral: Single Counseling Session']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPSB - Psychosocial Patient Support Booklet', 'description': 'will receive an American Cancer Society booklet for review (and no counseling)', 'interventionNames': ['Other: American Cancer Society booklet']}], 'interventions': [{'name': 'Single Counseling Session', 'type': 'BEHAVIORAL', 'description': 'The one-time counseling session will be a problem-solving focused program that will try to strengthen the belief in the ability to manage the challenges of the cancer diagnosis and treatment', 'armGroupLabels': ['SSC-C - Single Session Consultation for Cancer']}, {'name': 'American Cancer Society booklet', 'type': 'OTHER', 'description': 'called "After Diagnosis: A Guide for Patients and Families" for review. Again, this booklet includes information about cancer, living with cancer, making treatment decisions, talking to others about cancer, cancer treatment, and questions for the cancer care team. It will be given in person or by email.', 'armGroupLabels': ['PPSB - Psychosocial Patient Support Booklet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'phone': '646-888-8361'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (Consent Only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'phone': '646-888-8361'}], 'facility': 'Memorial Sloan Kettering Monmouth (Consent Only)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'phone': '646-888-8361'}], 'facility': 'Memorial Sloan Kettering Bergen (Consent Only)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'phone': '646-888-8361'}], 'facility': 'Memorial Sloan Kettering Suffolk- Commack (Consent Only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'phone': '646-888-8361'}], 'facility': 'Memorial Sloan Kettering Westchester (Consent Only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'phone': '646-888-8361'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'phone': '646-888-8361'}], 'facility': 'Memorial Sloan Kettering Nassau (Consent Only)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'Devika Jutagir, PhD', 'role': 'CONTACT', 'email': 'jutagird@mskcc.org', 'phone': '646-888-8361'}, {'name': 'Francesca Gany, MD, MS', 'role': 'CONTACT', 'phone': '646-888-8054'}], 'overallOfficials': [{'name': 'Devika Jutagir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The City College of New York', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}